TEACH Trial: Testing the Effect of Adding CHronic Azithromycin to Inhaled Tobramycin. A randomized placebo-controlled double-blinded trial of azithromycin 500mg thrice weekly in combination with inhaled tobramycin

Investigation of Azithromycin and Inhaled Therapy in Cystic Fibrosis

Recruiting
12 years - 100 years
All
Phase N/A
1 Location

Brief description of study.

This is a study to examine the effect of combining chronic oral azithromycin with inhaled tobramycin in adolescent and adult subjects with cystic fibrosis who are chronically infected with P. aeruginosa.

Detailed description of study

This study is a prospective, randomized, double-blinded, placebo-controlled trial of azithromycin 500mg taken orally thrice weekly vs. placebo in subjects with cystic fibrosis and chronic airway infection with P. aeruginosa who are utilizing chronic inhaled tobramycin therapy.
Participants will not be paid for their participation.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: cystic fibrosis
  • Age: 12 years - 100 years
  • Gender: All

Inclusion Criteria
Documented diagnosis of cystic fibrosis
At least two respiratory cultures growing P. aeruginosa within the last 12 months
Use of at least two cycles of inhaled tobramycin within the last 24 weeks
Off TISP and other inhaled anti-pseudomonal antibiotics for at least 2 weeks at Visit 1 and remain off of any inhaled antibiotics for an additional 2 weeks before starting inhaled tobramycin
Prior or current use of azithromycin for at least four consecutive weeks
Exclusion Criteria
Positive pregnancy test, lactating, or unwillingness to practice a pre-defined form of contraception, which includes abstinence
Inability or unwillingness to cycle off of inhaled tobramycin for one 4-week period and without Use of any additional inhaled antibiotics
Use of intravenous or oral anti-pseudomonal antibiotics within 4 weeks of screening
Use of investigational therapy within 4 weeks of screening
Use of systemic corticosteroids equivalent to a daily dose more than 10mg of prednisone
Use of nelfinavir, warfarin, haloperidol, or methadone (concern of drug interaction with azithromycin) modulator therapy within 30 days
Any other condition that, in the opinion of the site investigator, would compromise the safety of the subject or quality of the data

Updated on 19 Feb 2024. Study ID: 1708919614

This study investigates the effects of combining an investigational medication with inhaled therapy in people with cystic fibrosis who have a long-term infection with a specific bacteria called P. aeruginosa. Cystic fibrosis is a genetic condition that affects the lungs and digestive system. The study aims to see how this combination affects the health of the participants.

Participants will be randomly assigned to one of two study arms. One arm will receive the investigational medication, which is taken orally three times a week, while the other arm will receive a placebo, which is an inactive substance that looks like the investigational medication but does not contain any medicine. All participants will continue their usual inhaled therapy.

  • Who can participate: Eligible participants must have cystic fibrosis and a history of P. aeruginosa infection. They must have used inhaled therapy and be able to stop certain antibiotics for a specified period.
  • Study details: Participants will take either the investigational medication or a placebo orally three times a week. They will continue using their usual inhaled therapy. A placebo is an inactive substance that looks like the investigational medication but does not contain any medicine.

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